Senior Commissioning Engineer

STERIS Canada Corporation; Kuala Ketil; On-site; MYR 80,000 - 100,000; Full time

Job summary

A global healthcare supplier is seeking a Senior Commissioning Engineer to oversee validation projects in a fast-paced environment. The role requires strong regulatory knowledge and attention to detail to ensure compliance with FDA and ISO standards. The ideal candidate will have at least 2 years of experience and a Bachelor's Degree in Chemical Engineering. You'll collaborate closely with various departments and manage multiple projects efficiently.

Qualifications

• Minimum 2 years working experience in Validation Engineer or Commissioning Engineer.

Responsibilities

• Collaborates with Customers throughout all stages of Validation projects.
• Liaises with quality, operations, planning, and laboratory.
• Schedules and coordinates commissioning and recommissioning of sterilization chambers.

Skills

Regulatory knowledge of FDA, ISO, GMP

Attention to detail

Analytical and critical thinking

Project management skills

Education

Bachelor's Degree in Chemical Engineering or other technology

Job description

Position Summary

Senior Commissioning Engineer

Duties

• Collaborates with the Customers throughout all stages of their Validation projects.
• Liaises with quality, operations, planning, laboratory and Customer service.
• Prepares for, supports and where necessary facilitates both internal and external audits conducted by Customers, notified bodies and Regulatory Agencies.
• Conducts internal audits of the quality management systems as scheduled.
• Schedules, documents and coordinates commissioning and recommissioning of sterilization chambers.
• Provides and facilitates departmental, cross functional and Customer training in areas of Technical expertise.
• Maintains professional skills and knowledge by attending education workshops, reviewing professional publications and participating in professional forums and conferences.

Duties - cont'd

• Strong Regulatory Knowledge: Deep understanding of FDA, ISO, GMP, and other regulatory standards relevant to medical devices and sterilization processes.
• Meticulous Attention to Detail: Precision in validation protocols and reports is critical in a regulated manufacturing environment.
• Analytical and Critical Thinking: Ability to troubleshoot and analyze complex systems like autoclaves, cleanrooms, or sterile packaging processes.
• Adaptability and Flexibility: Comfortable working in a fast-paced environment with changing validation needs or priorities.
• Technical Curiosity: Eagerness to learn about new sterilization technologies and validation tools.
• Project Management Skills: Able to manage multiple validation projects, timelines, and documentation requirements efficiently.

Education Degree

Bachelor's Degree in Chemical Engineering or Other Technology

Required Experience

Minimum 2 years working experience in Validation Engineer or Commissioning Engineer

STERIS strives to be an Equal Opportunity Employer.